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Principal Design Engineer (Medical Device is a Must)

ATR International

Principal Design Engineer (Medical Device is a Must)

Irvine, CA
Full Time
Paid
  • Responsibilities

    Job Description

    Please let me know if you are interested in a position with a High Precision Manufacturing Company with off the shelf product cutting edge solutions. They offer a very nice working environment , friendly team members while developing designs for High Technology companies related to Medical Devices/ Instruments / Aerospace / Research Co.’s and various OEM’s. Thank you

    ATR Offers Great Benefits: Medical/Dental/Vision/ Weekly pay/Direct Deposit/ 401k and MUCH MORE!

    Requisition Number: ATR178087

    Job Title: Principal Design Engineer

    Job Location: Irvine, CA

    Job Duration: Indef.

    Job Description:

    We are seeking a Principal Design Engineer for a very important client.

    JOB SUMMARY:

    Works with and across the various disciplines of the engineering team, machine shop personnel, and assembly floor personnel for project realization, manufacturability, inspection, and assembly of product. One of the primary functions of the position is to create and develop designs that meet product specifications and requirements.

    JOB DUTIES:

    · Provides technical support to Management, Business Development, Engineering, Manufacturing, QA/RA, and Purchasing as needed or when requested.

    · Creates and develops designs from customer requirements to proof of concept to fully actualized and commercialized products.

    · Evaluates and troubleshoots problems, issues, or challenges in the design that may affect performance, manufacturing, inspection, and assembly processes to provide solutions.

    · Must be able to perform and demonstrate all developed and existing manufacturing, inspection, and assembly processes in a general hands on approach.

    · Gathers information for analysis to provide data on existing as well as proposed manufacturing, inspection, and assembly processes for good decision making. This may include calculating production costs through labor, methods/processes, time, equipment, and materials.

    · Works and collaborates with outside suppliers in acquiring information for new development requirements or in working through problems, issues, and/or challenges.

    · Complies with regulations and established company policies, procedures, and processes to ensure best practices are followed that ensure all products or processes meet specifications and/or requirements.

    · Attend or lead meetings as necessary as a part of team collaboration.

    · Mentor junior engineers.

    · Provide leadership in your functional area.

    · Performs other duties as assigned.

    Requirement:

    The ideal candidate will possess the following qualifications:

    SKILLS AND QUALIFICATIONS:

    · A Bachelor’s Degree of Science in Mechanical Engineering or related field is required. Advanced Degree is a plus.

    · A minimum of 7 years of related industry experience is required.

    · Design and development in regulated industries required, preferably medical device background and working knowledge of IEC 60601-x, ISO 13485.

    · Experience with design controls for medical devices Title 21 CFR 820 and ISO 13485 is preferred.

    · Experience with Risk Management ISO 14971 is preferred.

    · Experience with 3D Solid Modeling CAD software is required – Solidworks is a MUST!!!

    · Hands on experience with the design and development of small electromechanical systems/devices is preferred.

    · Must be familiar with Microsoft Project to schedule tasks, durations, with predecessor and successor relationships.

    · Experience and general understanding of operation and programming of Computer Numerically Controlled (CNC) equipment is required.

    · Experience with Design For Manufacturability/Inspection/Assembly (DFMIA).

    · Good understanding of ASME Y14.5 Geometric Dimensioning & Tolerancing (GD&T) and how it relates to the design, manufacturing, inspection, and assembly processes or procedures.

    · Able to conduct tolerance stack-up analysis is required.

    · Able to conduct stress analysis or analysis of the loading conditions on a design.

    · Able to understand and implement principles of Lean Methodology for improvements and gain efficiencies.

    · Able to apply statistical methods to analyze data for testing, manufacturing, inspection, and assembly processes. Able to gather information and data quickly and efficiently for analysis to provide direction and guidance for good decision making.

     

    ACCOUNTABILITY:

    · Assume responsibility and ownership of assigned tasks with minimal direction and guidance.

    · Exercise initiative and judgement with data driven decision making.

    · Provide support to team members, customers, and others in the company as required.

    · Assure all regulations, policies, procedures, or processes are followed as specified by the company.

    · Utilize standards and best practices where appropriate.

    · Maintain a safe working environment.

    · Hands on approach to problem solving.

    · Expected from time to time to put in extra time and effort to complete critical tasks to meet deadlines or objectives for the company.

     

    INTERPERSONAL AND COMMUNICATIONS SKILLS:

    · Team Environment: Must be able to work in a fast paced team environment and collaborate in a positive and professional manner. This may include taking on tasks and responsibilities overlapping with other team members.

    · Conflict: Must be able to negotiate and resolve issues with team members and management in a positive and professional manner.

    · Communication: Must be a strong communicator able to convey clear and concise information to team members, management, or customers. Good listening skills are required.

    · Ownership: Must be able to take ownership of problems, issues, or challenges with minimal guidance to troubleshoot and work through them.

    LANGUAGE SKILLS:

    Must possess the ability to read, write, speak, and comprehend the English language. Must be able to read, analyze, and interpret documents such as safety rules, operating and maintenance procedures

    Company Description

    ATR International is a staffing and consulting leader that serves the IT, engineering, accounting & finance, professional, manufacturing, and scientific industries. Founded in 1988 as a two-person Hispanic-owned business, we have grown to serve Fortune 500 organizations while putting more than 35,000 people to work totaling over 14 million working hours. Our entire business model is based on building relationships and deep connections with our diverse base of clients, contractors, internal staff, and local markets.